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Pharmaceuticals 22 July 2025 - 26 September 2025

Scholar Rock (SRRK) Just Hit a Regulatory Speed Bump—But the Long‑Term Muscle‑Building Story Still Has Legs

Scholar Rock (SRRK) Just Hit a Regulatory Speed Bump—But the Long‑Term Muscle‑Building Story Still Has Legs

The FDA issued a Complete Response Letter for Scholar Rock’s apitegromab on Sept. 23, citing only manufacturing issues at a third-party Indiana plant. Shares fell but analysts, including BMO and Leerink, maintained bullish outlooks, expecting a quick resolution. The EMA review continues, with a possible EU launch in late 2026. Scholar Rock reported $295 million in cash as of June 30.
26 September 2025
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Trump’s Tariff Tsunami: 100% Drug Tax and New Import Levies Rock Global Trade

Trump’s Tariff Tsunami: 100% Drug Tax and New Import Levies Rock Global Trade

President Donald Trump will impose a 100% tariff on branded and patented pharmaceutical imports starting October 1, unless manufacturers have begun building U.S. plants. New tariffs of 25% on heavy-duty trucks, 50% on cabinets, and 30% on upholstered furniture also take effect that day. Generic drugs are exempt. The EU and Japan say existing trade deals cap their pharma tariffs at 15%.
26 September 2025
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Big Pharma’s Billion-Dollar Bet: Inside Eli Lilly’s $5B Virginia Factory and America’s New Drug Manufacturing Boom

Big Pharma’s Billion-Dollar Bet: Inside Eli Lilly’s $5B Virginia Factory and America’s New Drug Manufacturing Boom

Eli Lilly will invest $5 billion to build a 200,000-square-foot drug manufacturing plant in Goochland County, Virginia, creating 650 permanent jobs and 1,800 construction jobs. The facility will produce active pharmaceutical ingredients for cancer and autoimmune treatments. The project is part of Lilly’s $27 billion U.S. expansion plan. Virginia approved over $10 million in incentives to secure the site.
16 September 2025
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COVID Booster Shocker, Pharma Mega-Deals & Alzheimer’s Breakthroughs – Global Health Roundup (Aug 28–29, 2025)

COVID Booster Shocker, Pharma Mega-Deals & Alzheimer’s Breakthroughs – Global Health Roundup (Aug 28–29, 2025)

The FDA approved updated COVID-19 boosters from Pfizer and Moderna but restricted them to seniors and high-risk groups, excluding healthy children. Infectious disease experts warned the move could leave millions unprotected. The CDC director was fired after refusing to follow anti-vaccine directives, triggering mass resignations among top officials.
29 August 2025
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Obesity Pill Breakthrough, Gene Therapy Triumph & Billion-Dollar Psychedelic Bet – Global Biotech & Health Highlights (Aug 26–27, 2025)

Obesity Pill Breakthrough, Gene Therapy Triumph & Billion-Dollar Psychedelic Bet – Global Biotech & Health Highlights (Aug 26–27, 2025)

Eli Lilly’s oral weight-loss drug orforglipron cut body weight by up to 10.5% in a Phase 3 trial for obese diabetics, with all doses meeting primary endpoints over 72 weeks. The FDA granted full approval to Precigen’s Papzimeos, the first gene therapy for adult recurrent respiratory papillomatosis. AbbVie agreed to acquire a psychedelic-based depression drug from Gilgamesh Pharmaceuticals in a deal worth up to $1.2 billion.
27 August 2025
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Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

The FDA approved Ionis Pharmaceuticals’ Dawnzera as the first RNA-targeted therapy to prevent hereditary angioedema attacks, priced at about $57,462 per dose. AbbVie’s Rinvoq met key endpoints in a second Phase 3 alopecia areata trial, while Scholar Rock’s apitegromab showed significant motor gains in spinal muscular atrophy. Gilead’s Kite Pharma will acquire Interius BioTherapeutics for $350 million.
23 August 2025
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Global Biotech & Health Roundup: Breakthrough Drugs, Big Deals & Policy Shifts (Aug 21–22, 2025)

Global Biotech & Health Roundup: Breakthrough Drugs, Big Deals & Policy Shifts (Aug 21–22, 2025)

The FDA approved Ionis’s Dawnzera for hereditary angioedema and Precigen’s Papzimeos for recurrent respiratory papillomatosis, marking a first for viral immunotherapy. Gilead’s Kite Pharma will acquire Interius BioTherapeutics for $350 million. Johnson & Johnson announced a $2 billion biomanufacturing facility in North Carolina. Apollo Hospitals’ managing director sold a $170 million stake in a major block trade.
22 August 2025
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Biotech Breakthroughs, Pharma Shakeups & Health Alerts – Global News Roundup (Aug 19–20, 2025)

Biotech Breakthroughs, Pharma Shakeups & Health Alerts – Global News Roundup (Aug 19–20, 2025)

CSL will cut up to 15% of its workforce and spin off its vaccine unit, targeting $500–550 million in annual savings. Medtronic agreed to add two board members and form new committees after Elliott Investment Management took a major stake. Merck KGaA and Skyhawk Therapeutics announced a neurological drug pact worth up to $2 billion. Pfizer, Bristol Myers Squibb, and Regeneron reported improved Q2 2025 earnings.
20 August 2025
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Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)

Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)

Genentech is ending its $2 billion cell therapy partnership with Adaptive Biotechnologies, citing cost-cutting but no safety issues. Kriya Therapeutics raised $313 million in Series D funding, one of the year’s largest biotech rounds. The FDA delayed Neurizon’s ALS drug trial review until October due to staffing shortages. Stealth BioTherapeutics has resubmitted its elamipretide application for Barth syndrome after two FDA rejections.
19 August 2025
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Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Wegovy became the first GLP-1 therapy approved by the FDA for MASH, affecting about 5% of U.S. adults. Tonix’s Tonmya was cleared for fibromyalgia, the first new therapy in 15 years. Pfizer’s inclacumab failed a key sickle cell trial, and Oxbryta was withdrawn. BioNTech agreed to acquire CureVac in a $1.25 billion all-stock deal.
16 August 2025
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Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

China researchers reported a hydrogel “smart” wound dressing that closed 90% of diabetic ulcers in mice within 12 days by delivering microRNA vesicles. The FDA approved Boehringer Ingelheim’s Hernexeos for advanced non-squamous NSCLC, with 75% of treated patients seeing tumors shrink or disappear. U.S. IV saline shortages ended as Baxter’s North Carolina plant resumed production after hurricane damage.
10 August 2025
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Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

On July 2, 2025, the FDA granted accelerated approval to linvoseltamab for relapsed/refractory multiple myeloma and approved sunvozertinib as the first targeted oral therapy for advanced NSCLC with EGFR exon 20 insertion mutations. The FDA also cleared denosumab biosimilars for osteoporosis, and Senegal was declared free of trachoma by the WHO.
22 July 2025
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